The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.
Sage Therapeutics, Inc. and Biogen, Inc. have again pushed out their filing plans for the antidepressant zuranolone, but their plan provides a clearer – albeit slightly riskier – path to market than before.
The companies said 19 October that they would file with the US Food and Drug Administration for zuranolone in major...
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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